MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W 1UB II BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72201991

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

It was reported that the distal end of the anchor broke off upon insertion.A backup device was readily available and no patient injury was reported.

Manufacturer Narrative

Examination was not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.A review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified one additional complaint for this manufactured lot.

• Brand Name: OSTEORAPTOR 2.3 W 1UB II BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6976803
• MDR Text Key: 90795530
• Report Number: 1219602-2017-01333
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615527
• UDI-Public: (01)03596010615527(17)220731(10)50677304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 72201991
• Device Catalogue Number: 72201991
• Device Lot Number: 50677304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1